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28 May 2016

USFDA rejected AstraZeneca’s potential blockbuster hyperkalemia drug ZS-9

AstraZeneca acquired ZS Pharma in Nov 2015 for its potential blockbuster hyperkalemia drug ZS-9. ZS Pharma is focused on the development and commercialisation of highly selective, non-absorbed drugs to treat renal, cardiovascular, liver and metabolic disorders.
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AstraZeneca today announced that the US Food and Drug Administration (FDA) has issued a Complete Response Letter (CRL) regarding the New Drug Application (NDA) for sodium zirconium cyclosilicate (ZS-9), the investigational medicine being developed for the treatment of hyperkalaemia (high potassium level in the blood serum) by ZS Pharma, a wholly-owned subsidiary of AstraZeneca.
The FDA rejection of ZS-9 came following to after finding issues in a pre-approval manufacturing inspection. The FDA also acknowledged receipt of recently-submitted data which it has yet to review. The CRL does not require the generation of new clinical data. AstraZeneca and ZS Pharma are evaluating the content of the CRL and will work closely with the FDA to determine the appropriate next steps for the NDA.

Generally in this kind of scenario, company should again try to resubmit the data to get the approval. But it may take even additional 9-12 months or even more time. In fact drug approval timeline is uncertain. There will be chance that USFDA may reject the same. This process will reduce the drugs effective marketing time and also incur additional development cost. But already company spent so much and molecule in final stage, so there is no point in dropping, company should persist with the same and try to resolve the issue as mentioned in CRL.
About ZS-9
Sodium zirconium cyclosilicate (ZS-9) is an insoluble, non-absorbed compound with a structure that was designed to preferentially trap potassium ions. The unique potassium selectivity of sodium zirconium cyclosilicate enables high in-vitro binding capacity for potassium ions even in the presence of other competing ions. Sodium zirconium cyclosilicate has been studied in three double-blind, placebo controlled trials and in one ongoing 12 month open label clinical trial in patients with hyperkalemia which represents over 1,600 patients treated. Sodium zirconium cyclosilicate is an investigational product that is not currently approved for any indication in any market.
About Hyperkalemia
Hyperkalaemia (high potassium levels > 5.0 mEq/L in the blood serum) occurs in 23-47% of patients with advanced chronic kidney disease and/or chronic heart failure, and may lead to cardiac arrest and death (mortality of up to 30% in patients with severe hyperkalaemia if not treated rapidly). Treatment with common heart medicines (RAAS inhibitors) can also be responsible for increases in hyperkalaemia. Current therapeutic options are limited, leaving high unmet medical need.

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